# K160564: TroClose1200

- Pathway: 510(k) (Traditional)
- Applicant: Gordian Surgical, Ltd.
- Decided: Nov 17, 2016 after 262 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011257 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123280: Neoclose Hasson, Neoclose Universal, Neosurgical, Ltd. (2013) Summary page 4.
- K130435: Versaport V2 Bladeless Optical Trocar, Covidien, Formerly US Surgical A Divison of Tyco H (2013) Summary page 4.

## Most influential descendants
- K253620: TroClose 1200 (2025), 0 descendants of its own

## Recalls of this device
- Sep 22, 2020 · Class II · Z-0398-2021: Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).

## Indications for use
The TroClose1200™ bladeless trocar is intended for use in a variety of gynecologic, general and urologic endoscopic procedures to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic/ laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions.

Source page: https://510kreport.com/device/K160564
Methodology: https://510kreport.com/methodology